NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors
Design: This is a dose-escalation, single-center, open-label, prospective Phase 1 study. A total of 18 subjects will be enrolled and assigned to 2 administration groups (9 subjects each): Group A (Intravenous infusion): For subjects with small-volume malignant ascites. Group B (Intraperitoneal perfusion): For subjects with large-volume symptomatic malignant ascites. Each group will follow a conventional 3+3 dose-escalation design with 3 dose levels (1×10⁹, 3×10⁹, 6×10⁹ NK cells per dose), administered once weekly, 3 weeks per cycle, for 2 consecutive cycles. Primary
Objectives: To evaluate the safety and tolerability, and to determine the dose-limiting toxicity (DLT) of NK521 administered intravenously and intraperitoneally. Secondary Objectives: To assess the preliminary anti-tumor efficacy including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), puncture-free survival (PuFS), and changes in tumor markers, as well as health-related quality of life (HRQoL).
• Pathologically diagnosed with relapsed/refractory advanced solid tumors, including but not limited to liver cancer, gastric cancer, colorectal cancer, ovarian cancer, etc.
• Complicated with malignant ascites with identifiable tumor cells in ascites. Patients with advanced solid tumors who have failed at least 2 lines of standard therapy.
• At least one measurable lesion on CT or MRI per RECIST v1.1.
• ECOG performance status 0-2.
• Life expectancy ≥3 months.
• All toxicities from prior antineoplastic therapy have resolved to Grade 1 (CTCAE v5.0) or baseline except alopecia and fatigue; subjects with long-term stable sequelae from prior therapy (e.g., platinum-induced neuropathy) are allowed.
• Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment; all subjects must agree to use contraception from signing informed consent until 6 months after the last NK521 infusion.
• Able to comply with the study protocol and follow-up procedures.
• Voluntarily signed and provided written informed consent.